System Engineer IV
Durham, NC, US, 27703
- Own top-level system requirements and system architecture, translating user needs into defined and approved product requirements.
- Serve as Technical Lead on the Product Ownership Team and guide system-level design decisions throughout the development lifecycle.
- Evaluate system performance and conduct trade-off analyses involving reliability, cost, schedule, manufacturability, safety, and technical risk.
- Lead system integration and test planning, review verification plans and procedures, and confirm traceability between requirements and verification testing.
- Coordinate external system testing with Compliance Engineering and notified bodies such as TÜV and UL.
- Support system risk analysis, configuration management, Agile development activities, sustaining engineering, and documentation of system changes.
- BS, MS, or PhD in Electrical Engineering, Physics, Electrical Computer Engineering, Computer Science, or a related field.
- 8+ years of regulated-industry experience, including 5+ years as a Systems Engineer or in a similar role.
- Experience across the product development lifecycle in a highly regulated industry.
- Solid understanding of software-design methodologies and deliverables, safety methodologies such as IEC 60601 or similar standards, and microprocessor-controlled systems.
- Broad understanding of analog and digital hardware design, with general knowledge of optical and mechanical design.
- Expert-level ability to document and communicate system engineering and design deliverables.
- Strong analytical thinking, complex problem-solving, critical thinking, and decision-making capabilities.
- Excellent written and verbal communication, stakeholder management, collaboration, and organizational skills.
- Ability to evaluate system architectures, integration methods, performance trade-offs, technical risks, and changes in scope.
- Experience designing medical systems or similarly complex systems is preferred.
- Knowledge of medical-device quality standards and regulations, image-acquisition systems, image-processing techniques, communications networks, and complex-system testing is preferred.
- Strategic thinking, creativity, innovation, and the ability to mentor others.
KARL STORZ is committed to maintaining a safe work environment for our employees and customers. Most field-based roles at KARL STORZ require hospital credentialing/health screens as a condition of employment. Credentialing can include required vaccinations, health screens & other requirements as outlined by our customers. During the interview process, we encourage you to ask how credentialing/health screens may impact the role you are seeking and if you require any reasonable accommodations regarding these requirements.
The pay range and/or hourly pay rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job posting and may be modified in the future. When determining a specific team member’s base salary and/or hourly pay rate, several factors will be considered including such things as location, specialty, service line, years of relevant experience, education, professional credentials, internal equity, and the amount budgeted for the role.
KARL STORZ is committed to creating an inclusive space where employees are valued for their skills and unique experiences. To achieve this goal, we are committed to diverse voices, and all applicants will receive consideration without regard to race, color, sex, national origin, disability, veteran status, or any other protected characteristic. KARL STORZ is also committed to providing reasonable accommodations during our recruitment process. Should you need assistance or accommodation please email us at taoperations@karlstorz.com.
Nearest Major Market: Durham
Nearest Secondary Market: Raleigh